BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZIO

    MDR report key: 18588140 · Received January 25, 2024

    Report

    Report Number
    MW5150745
    Event Type
    Death
    Date Received
    January 25, 2024
    Date of Event
    January 1, 2024
    Report Date
    January 22, 2024
    Manufacturer
    IRHYTHM TECHNOLOGIES, INC.
    Product Code
    DSI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ALL FAMILY WERE TOGETHER FOR NEW YEAR. MY MOM WAS FINE BUT FOR COUPLE OF WEEKS SHE COMPLAINED ABOUT DIZZINESS AND FATIGUE. SHE REPORTED THAT TO HER PHYSICIAN, BUT THEY DIDN'T CHANGE HER MEDICATIONS. MY MOM WENT HOME WITH MY DADA AND SHE SAID SHE CANNOT BREATH AND SHE COLLAPSED. SHE [PASSED AWAY ON JANUARY 1ST DUE TO LUNG HEMORRHAGE WHICH LED TO HYPOXIA AND CARDIAC ARREST. SHE DIDN'T HAVE ANY LUNG PROBLEM IN HER WHOLE LIFE, HER DOCTOR STARTED OZEMPIC FOR HER TO WEIGHT LOSS AND CARDIAC BENEFIT. SHE WAS ON XARELTO TOO FOR HER AFIB. SHE ALSO HAD FLUTTER AND WAS SENT HOME WITH A DEVICE THAT HAD RECALL ON IT. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838920 ZIO DETECTOR AND ALARM, ARRHYTHMIA DSI IRHYTHM TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Death FUROSEMIDE | MAGNESIUM| METOPROLOL| MULTIVITAMIN | OZEMPIC| SOTALOL| SPIRONOLACTONE| XARELTO